INFORMED CONSENT A description of the rationale and process for obtaining and maintaining valid informed consent from study participants is in the IRB Policies and Procedures. An essential elements list based on Schedule Y is also included in the section on informed consent. A sample patient information sheet and informed consent form are provided below. SAMPLE Christian Medical College, Vellore Department of XXX A randomized trial comparing adjunctive Modafinil with placebo for clozapine related adverse effects in people with schizophrenia or schizoaffective disorder in remission. Information sheet You are being requested to participate in a study to see if a drug called Modafinil can help you with the side effects of increased sleepiness and increased saliva formation caused by Clozapine that has been prescribed to treat you. These are common side effects of Clozapine and many people given Clozapine suffer from these problems. There are other drugs that can help with these but we do not know of any that can help both at the same time. We hope to include about 70 people from this hospital in this study. What does Modafinil do when taken along with Clozapine? We have observed that when people who are sleepy in the daytime and sleeping long hours at night on Clozapine are given Modafinil, it keeps them awake and alert during the day. Modafinil has also helped reduce and even stop the increased salivation that had been a problem with Clozapine treatment. Modafinil also reduces appetite and many people lose some or all of the weight they had gained while taking Clozapine. However, we have only used this for a few people taking clozapine and we need to use it for more people to be sure it really helps Does Modafinil have any side effects? Modafinil has been used by many people all over the world to help reduce excessive sleep due to a variety of problems, including that caused by medicines. The majority of people have not had any side effects. Some people on Modafinil have experienced some side effects such as headache, feeling anxious, feeling like vomiting, loose motion and stomach discomfort, but these were usually mild and temporary. Modafinil does not cause addiction or any problems when it is stopped suddenly. It may cause mild increases in blood pressure but these are usually not serious. It is not known to cause any problems to the heart. Rarely, it can cause a worsening of the psychiatric problem but this has been observed only at doses higher than what we plan to use in this study. If you take part what will you have to do? If you agree to participate in this study, you will be given either one table of Modafinil to be taken every morning, or an identical looking tablet that does not contain Modafinil, for a total period of 9 weeks. Using thus dummy tablet will help us be sure that any improvement in your sleepiness or increased saliva formation is actually due to Modafinil and not due to chance (coincidence) or normal fluctuations in your condition. Neither you nor your doctor will have any choice in whether you will get Modafinil or the dummy tablet as this will be decided by a computer program; this is like tossing a coin and you have an equal chance of getting either tablet. Also, neither you nor your doctor will know which tablet you are taking till the study is over. All other treatments that you are already on will be continued and your regular treatment will not be changed during this study. You will be expected to come for a review to the hospital 2 weeks after starting the tablet and again after 4 more weeks and finally after a further 4 weeks. Before starting the study and at each visit you will be asked questions about your sleep, saliva formation, activities, how you feel and about any side effects. Your weight and blood pressure will also be recorded at each visit. No additional procedures or blood tests will be conducted routinely for this study. If at any time you experience any problems, you will be expected to report this to the doctor. You will also be contacted by telephone at least once in between the monthly visits by the doctors in this study who will ask you about any side effects you are experiencing. Can you withdraw from this study after it starts? Your participation in this study is entirely voluntary and you are also free to decide to withdraw permission to participate in this study. If you do so, this will not affect your usual treatment at this hospital in any way. In addition, if you experience any serious side effects or your condition worsens, the study tablets will be stopped and you may be given additional treatment. What will happen if you develop any study related injury? We do not expect any injury to happen to you but if you do develop any side effects or problems due to the study, these will be treated at no cost to you. We are unable to provide any monetary compensation, however. Will you have to pay for the study tablets? Both Modafinil and dummy tablets will be given free for a total period of 9 weeks. We will also reimburse you and one person accompanying you the money that you spent on travel to come for review (please keep your bus or train tickets) for the visits that you make for this study. Any other treatment that you usually take will continue but the usual arrangements that you have with the hospital will decide how much you pay for this. What happens after the study is over? You may or may not benefit from the study drug that you are given. Once the study is over, if the tablet you were given is Modafinil and if it has helped you and you wish to continue, then your doctor may prescribe it for you. If you were given the dummy tablet and Modafinil has helped the people who took it, then your doctor will give you the choice of taking Modafinil. However, this will not be part of the study and you may have to pay for it. Will your personal details be kept confidential? The results of this study will be published in a medical journal but you will not be identified by name in any publication or presentation of results. However, your medical notes may be reviewed by people associated with the study, without your additional permission, should you decide to participate in this study. If you have any further questions, please ask Dr.XXX, Dr. XXX or Dr. XXX (tel: 0416 228XXX/ 228XXX/ 228XXX) or email: xxx@cmcvellore.ac.in SAMPLE CONSENT TO TAKE PART IN A CLINICAL TRIAL Study Title: A randomized trial comparing adjunctive Modafinil with placebo for clozapine related adverse effects in people with schizophrenia or schizoaffective disorder in remission. Study Number: Participant’s name: Date of Birth / Age (in years): I_____________________________________________________________ ___________, son/daughter of ___________________________________ (Please tick boxes) Declare that I have read the information sheet provide to me regarding this study and have clarified any doubts that I had. [ ] I also understand that my participation in this study is entirely voluntary and that I am free to withdraw permission to continue to participate at any time without affecting my usual treatment or my legal rights [ ] I also understand that neither I, nor my doctors, will have any choice or knowledge of whether I will get Modafinil or the identical looking dummy tablet [ ] I also understand that during the 9 weeks of the study, the Modafinil or dummy tablet will be provided free, but after this, if Modafinil is prescribed, I may have to pay for it [ ] I understand that I will receive free treatment for any study related injury or adverse event but I will not receive and other financial compensation [ ] I understand that the study staff and institutional ethics committee members will not need my permission to look at my health records even if I withdraw from the trial. I agree to this access [ ] I understand that my identity will not be revealed in any information released to third parties or published [ ] I voluntarily agree to take part in this study [ ] Name: Signature: Date: Name of witness: Relation to participant: Date: